Prospective and Observational Study of Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025. (EPOOzo)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change from Baseline in the health-related quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at the end of ozone therapy)
研究概览
简要总结
The main objective of this study is to analyze the impact on the health-related quality of life of patients with refractory symptoms, who have been referred to the HUGCDN Chronic Pain Unit for adjuvant palliative treatment with ozone therapy between June-2022 and December-2025
详细描述
Chronic Pain Unit in the absence or failure of standard treatment, or when the standard treatment is associated with high morbidity or high risk. Frequently, these patients present alterations in self-perceived health-related quality of life (HRQoL), anxiety, depression, and other symptoms. This study aims to evaluate in these patients the effect of adjuvant symptomatic/palliative ozone therapy on the HRQoL and the potential changes from baseline on several parameters after treatment.
MAIN OBJECTIVES: To evaluate in these patients: 1) the clinical effect on the HRQOL of adding ozone to the standard treatment.
SECONDARY OBJECTIVES: To evaluate in these patients changes from baseline on 2) anxiety and depression, 3) pain (if applicable), 4) grade of toxicity (if applicable), 5) requirements of invasive procedures for symptom management, 6) evolution of main symptoms, 7) evolution of oxidative stress and inflammation (if systemic ozone therapy).
METHODOLOGY: Prospective and observational study of patients referred to our Chronic Pain Unit for symptomatic/palliative treatment with ozone therapy between 2022 and 2025.
MAIN VARIABLE: 1) HRQoL through the EQ-5D-5L questionnaire
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > = 18 years old.
- •Patients submitted to the Chronic Pain Unit of the Hospital Universitario de Gran Canaria Dr. Negrín for symptomatic/palliative treatment with ozone therapy because conventional treatment does not exist, it has been unsuccessful, or it is associated with high risk or high morbidity.
- •After evaluation of symptoms and patients, it exists a potential benefit of adding ozone treatment to the current treatment.
- •Patients have no contraindications for ozone treatment.
- •Patients have signed and dated the informed consent for the compassionated ozone treatment and the specific informed consent for this study
排除标准
- •Age < 18 years old.
- •Psychiatric illness or social situations that would limit compliance with study requirements.
- •Those who are incapable to fill in the scales used to measure variables.
- •Hemodynamically or clinically unstable patients or uncontrolled severe illness.
- •Uncontrolled cancer disease requiring chemotherapy treatment.
- •Life expectancy < 6 months
- •Contraindication or disability or to attend scheduled treatments.
- •Known allergy to ozone.
- •Pregnancy at the time of enrollment (for systemic ozone therapy). 10 Hemochromatosis (for systemic ozone therapy).
- •11. Known significant glucose-6-phosphate dehydrogenase deficiency (favism, acute hemolytic anemia) (for systemic ozone therapy).
- •12. Patients who do not meet all the inclusion criteria
结局指标
主要结局
Change from Baseline in the health-related quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at the end of ozone therapy)
时间窗: 16 weeks
Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)
次要结局
- Change from Baseline in Levels of anxiety and depression according to the hospital anxiety/depression scale (at the end of ozone therapy)(16 weeks)
- Change from Baseline in pain score according to the visual analog scale (VAS) (at the end of ozone therapy)(16 weeks)
- Change from Baseline in the grade of toxicity secondary to cancer-treatment (if applicable) according to the CTCAE v5.0 scale (at the end of ozone therapy)(16 weeks)
- Changes from Baseline in requirements of invasive procedures (surgery, blood transfusions, and therapeutic endoscopic procedures) required for symptom management (at the end of ozone therapy)(16 weeks)
- Changes from Baseline in the main symptoms (at the end of ozone therapy)(16 weeks)
- Changes from Baseline in biochemical parameters of oxidative stress (if systemic ozone therapy) (at the end of ozone therapy).(16 weeks)
- Changes from Baseline in biochemical parameters of inflammation (if systemic ozone therapy) (at the end of of ozone therapy).(16 weeks)
- Change from Baseline in the health-related quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire.(40 weeks)
- Change from Baseline in Levels of anxiety and depression according to the hospital anxiety/depression scale.(40 weeks)
- Change from Baseline in pain score according to the visual analog scale (VAS).(40 weeks)
- Change from Baseline in the grade of toxicity secondary to cancer-treatment (if applicable) according to the CTCAE v5.0 scale.(40 weeks)
- Changes from Baseline in requirements of invasive procedures (surgery, blood transfusions, and therapeutic endoscopic procedures) required for symptom management.(40 weeks)
- Changes from Baseline in the main symptoms.(40 weeks)
- Changes from Baseline in biochemical parameters of oxidative stress (if systemic ozone therapy).(40 weeks)
- Changes from Baseline in biochemical parameters of inflammation (if systemic ozone therapy).(40 weeks)
研究者
Bernardino Clavo, MD, PhD
MD, PhD, Head of Research Unit
Dr. Negrin University Hospital